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Spots Global Cancer Trial Database for Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors

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Trial Identification

Brief Title: Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors

Official Title: Open, Two-stage, Multicenter, Monotherapy, Phase II Clinical Study of Utidelone Injection in Patients With Advanced or Metastatic Solid Tumors After Failure or Intolerability to Standard Treatment

Study ID: NCT04911907

Conditions

Solid Tumor

Interventions

utidelone injection

Study Description

Brief Summary: This trial is an open, two-stage, multi-center, phase II clinical trial to evaluate the efficacy and safety of Utidelone in advanced solid tumors (excluding breast cancer, lung cancer, and colorectal cancer) that have failed standard of treatment or were unable to perform standard treatment. This trial is divided into 2 stages, screening stage and expansion stage. In the screening stage, 10 patients were enrolled for each tumor type(including Squamous cell carcinoma of head and neck, Esophageal cancer, Stomach cancer, Pancreatic cancer, Cholangiocarcinoma, Ovarian cancer and Other solid tumors). Based on the results of the tumor type screening stage, the sponsor and the main investigator will have a discussion and have the alignment of tumor types to enter the expansion stage. The expansion stage will refine the inclusion / exclusion criteria and may adjust the treatment plan based on the tumor type and the combination drug selection. A total of 30-50 patients (including patients enrolled in the screening stage) were enrolled in each specified tumor type during the expansion stage.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Luhe Hospital, Capital Medical University, Beijing, , China

Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, , China

Shanghai East Hospital of Tongji University, Shanghai, , China

Contact Details

Name: JIN LI, MD

Affiliation: Shanghai Tongji University Affiliated Oriental Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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